Buspirone Therapy for Localized Epilepsy
| Status: | Terminated |
|---|---|
| Conditions: | Anxiety, Depression, Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/5/2019 |
| Start Date: | November 22, 2011 |
| End Date: | April 19, 2016 |
A Phase Two Clinical Trial of Buspirone Therapy in Localization-Related Epilepsy
Background:
- Buspirone is a drug that is approved for the treatment of anxiety in adults. Studies
suggest that buspirone might act on parts of the brain that can increase certain levels of
brain activity. Increasing this brain activity may help decrease epileptic seizures that come
from certain parts of the brain. Researchers want to see if buspirone can reduce seizure
frequency in people with seizures who are already taking antiseizure medication.
Objectives:
- To test whether buspirone can reduce the frequency of seizures in people whose seizures
seem to start from one part of the brain.
Eligibility:
- Individuals between 18 and 65 years of age who have seizures coming from one or more
places in the brain.
- Participants must have tried at least two different antiseizure medications. They must
also have had at least three seizures during a 1-month observation period while on
current medicines.
Design:
- Participants will have a screening visit with a physical exam and medical history.
Participants will complete mood and memory testing scales. Blood, urine, and saliva
samples will be collected.
- Participants will have a magnetic resonance imaging scan to evaluate brain structures
that relate to epilepsy. They will also have a positron emission tomography scan to look
at parts of the brain that are affected by buspirone.
- Participants will start taking a study drug (either buspirone or placebo) twice daily.
They will keep a calendar of seizures and record any side effects. Treatment will be
monitored with clinic visits and blood samples.
- After 12 weeks on the study drug, participants will gradually stop taking either the
placebo or buspirone over two weeks. They will stay off the drug for another 2 weeks.
- After 2 weeks, participants will start taking a study drug that is the opposite of the
one they had before. They will keep a calendar of seizures and record any side effects.
Treatment will be monitored with clinic visits and blood samples.
- After 12 weeks on the study drug, participants will gradually stop taking either the
placebo or buspirone.
- Participants will have a final followup visit with additional blood tests, mood and
memory testing scales and imaging studies....
- Buspirone is a drug that is approved for the treatment of anxiety in adults. Studies
suggest that buspirone might act on parts of the brain that can increase certain levels of
brain activity. Increasing this brain activity may help decrease epileptic seizures that come
from certain parts of the brain. Researchers want to see if buspirone can reduce seizure
frequency in people with seizures who are already taking antiseizure medication.
Objectives:
- To test whether buspirone can reduce the frequency of seizures in people whose seizures
seem to start from one part of the brain.
Eligibility:
- Individuals between 18 and 65 years of age who have seizures coming from one or more
places in the brain.
- Participants must have tried at least two different antiseizure medications. They must
also have had at least three seizures during a 1-month observation period while on
current medicines.
Design:
- Participants will have a screening visit with a physical exam and medical history.
Participants will complete mood and memory testing scales. Blood, urine, and saliva
samples will be collected.
- Participants will have a magnetic resonance imaging scan to evaluate brain structures
that relate to epilepsy. They will also have a positron emission tomography scan to look
at parts of the brain that are affected by buspirone.
- Participants will start taking a study drug (either buspirone or placebo) twice daily.
They will keep a calendar of seizures and record any side effects. Treatment will be
monitored with clinic visits and blood samples.
- After 12 weeks on the study drug, participants will gradually stop taking either the
placebo or buspirone over two weeks. They will stay off the drug for another 2 weeks.
- After 2 weeks, participants will start taking a study drug that is the opposite of the
one they had before. They will keep a calendar of seizures and record any side effects.
Treatment will be monitored with clinic visits and blood samples.
- After 12 weeks on the study drug, participants will gradually stop taking either the
placebo or buspirone.
- Participants will have a final followup visit with additional blood tests, mood and
memory testing scales and imaging studies....
OBJECTIVE:
To initiate a pilot clinical trial assessing the safety, tolerability and efficacy of the
5HT1A receptor agonist buspirone in patients with localization-related epilepsy. Buspirone is
a 5HT1A receptor agonist that is approved for the treatment of anxiety disorders. Patients
with localization-related epilepsy have reduced 5HT1A receptor binding on 18FCWAY positron
emission tomography (PET). Increasing neurotransmitter activity at 5HT1A receptor sites may
ameliorate seizures.
STUDY POPULATION:
Forty patients with localization-related epilepsy
DESIGN:
A randomised, double-blind, placebo-controlled cross-over, phase II clinical trial.
The trial will have a screening phase in which each patient will undergo physical and
neurological examination, and standard blood tests, followed by a one month baseline phase.
At the end of baseline, patients who qualify will have neuropsychological, anxiety, and mood
evaluation, FCWAY PET and MRI (if imaging was not performed already). During the subsequent
first study phase, patients will be randomized to buspirone or matching placebo. After
completion of the first study phase, patients will be crossed over to the alternate study
arm. At the end of the study, any patient who wishes to do so may remain on open-label
buspirone.
OUTCOME MEASURES:
1. Difference in seizure rate comparing the 3 month placebo and active study phases
2. Neuropsychological, anxiety, and mood indices comparing the 3 month placebo and active
study drug phases
To initiate a pilot clinical trial assessing the safety, tolerability and efficacy of the
5HT1A receptor agonist buspirone in patients with localization-related epilepsy. Buspirone is
a 5HT1A receptor agonist that is approved for the treatment of anxiety disorders. Patients
with localization-related epilepsy have reduced 5HT1A receptor binding on 18FCWAY positron
emission tomography (PET). Increasing neurotransmitter activity at 5HT1A receptor sites may
ameliorate seizures.
STUDY POPULATION:
Forty patients with localization-related epilepsy
DESIGN:
A randomised, double-blind, placebo-controlled cross-over, phase II clinical trial.
The trial will have a screening phase in which each patient will undergo physical and
neurological examination, and standard blood tests, followed by a one month baseline phase.
At the end of baseline, patients who qualify will have neuropsychological, anxiety, and mood
evaluation, FCWAY PET and MRI (if imaging was not performed already). During the subsequent
first study phase, patients will be randomized to buspirone or matching placebo. After
completion of the first study phase, patients will be crossed over to the alternate study
arm. At the end of the study, any patient who wishes to do so may remain on open-label
buspirone.
OUTCOME MEASURES:
1. Difference in seizure rate comparing the 3 month placebo and active study phases
2. Neuropsychological, anxiety, and mood indices comparing the 3 month placebo and active
study drug phases
- INCLUSION CRITERIA:
- Patients may be male or female.
- Patients will be aged 18 65
- Patients must have at least 3 seizures during the one-month baseline.
- Localization-related epilepsy diagnosed by standard clinical criteria that has not
responded to treatment with two standard antiepileptic drugs either sequentially or in
combination.
- Patients must be able to provide informed consent
- Patients must be able to remain on their baseline AED drugs and doses throughout the
study
- Patients must be able to use seizure calendars to record seizures throughout the
trial.
EXCLUSION CRITERIA:
- Pregnant patients will not participate in the study.
- During the study, women of child-bearing potential must use a reliable method of birth
control and will have pregnancy testing throughout the protocol.
- Use of any alcohol or recreational drugs starting two weeks before entering baseline
and for the duration of the study.
- Patients on medications with potential for a clinically significant interaction with
buspirone, including MAO inhibitors, clozapine, zolpidem, hypnotics, hydromorphone
derivatives, oxycodone, and
diltiazem.
- Current treatment for psychiatric disorder other than depression, anxiety or bipolar
disorder.
- Patients with a diagnosis of schizophrenia.
- Current treatment for another significant medical disorder, such as diabetes, or heart
disease, or an untreated disorder, that might interfere with the study.
- Calculated Creatinine clearance of less than 80 ml/min calculated with the
Cockcroft-Gault formula:
- Clcr = [(140-age) times ideal body weight in Kg] times (0.85 if female) divided by (72
times serum Cr in mg/dL)
- Evidence of impaired liver function based on serum chemistries.
- Inability to participate in the study procedures, such as MRI, PET, seizure and
adverse event recording, or drug titration
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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